MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III COLONOVIDEOSCOPE; FLEXIBLE VIDEO COLONOSCOPE, REUSABLE

Model Number PCF-H190L

Device Problem Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2022

Event Type  malfunction  

Event Description

As reported for this event by the customer, concern was raised for the reprocessing across multiple customer sites upon findings after devices were inspected with a borescope.The findings of a borescope inspection for this device is light dimpling.The device is showing wear.The device was soaked and re-cleaned.The borescope was put in the device backward through the suction connector (christmas tree type) on the scope connector and all of the way up where the umbilical cord meets the control body.It was observed that the brushes did not touch the channel wall on the side that the debris is being found.There is no reported harm to any patient or persons.

Manufacturer Narrative

Customer (b)(6) facilities had concerns connected with reprocessing of devices at the various iu health facilities.Arising from this concern, devices/events have been identified for the (b)(6) facilities below: (b)(6).The associated devices/events that are identified at this time for (b)(6) hospital are as below: patient identifier: (b)(6), model number pcf-h190l, serial number (b)(4); (b)(6), pcf-h190l, (b)(4); (b)(6), gif-1th190, (b)(4); (b)(6), gif-h190, (b)(4); (b)(6), sif-q180, (b)(4); (b)(6), gif-h190, (b)(4); (b)(6), gif-h190, (b)(4); (b)(6), gf-uct180, (b)(4); (b)(6), pcf-h190l, (b)(4); (b)(6), tjf-q190v, (b)(4); (b)(6), tjf-q190v, (b)(4) (first event); (b)(6), tjf-q190v, (b)(4) second event.This medwatch is for patient identifier: (b)(6).In-service was performed by the olympus endoscopy support specialist (ess) for the facility¿s reprocessing.The cleaning, disinfection, and sterilization information was reviewed during in-service and documented.Below are the observations made: during reprocessing in-service it was observed that the customer uses the channel opening cleaning brush prior to using the channel cleaning brush.The brushing is done in the incorrect order.The customer uses third party brushes.The customer also does not wipe the scope down after the flushing with detergent solution and does not let it soak for the detergent manufacturer's recommended time.The scope does not soak at all and goes directly into the rinse sink.The customer uses intercept detergent.The customer uses the scope buddy plus for flushing and the medivator¿s advantage plus pass through automatic endoscopy reprocessor (aer).The correct reprocessing method per the instructions for use (ifu) were reviewed in the in-service.Customer manager was provided with a copy of the documentation of the in-service, posters, and websites for reprocessing videos.The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time.This event is under investigation.A supplemental report will be submitted upon completion of the investigation or upon receiving additional information.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 10 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomena were presumed to have been due to improper reprocessing of the device.It was considered that the user¿s understanding differed from the manufacturer's recommendation in scope handling and/or reprocessing steps.The user¿s reprocessing steps deviated from the instructions for use (ifu) as follows: "- they do not follow the correct brushing order during manual cleaning.Brushing steps are detailed at ¿5.5 manually cleaning the endoscope and accessories brush the channels¿¿¿.- they do not wipe the scope down after flushing with detergent solution and do not let it soak for the detergent manufacturer's recommended time.Dry external surfaces: dry the external surfaces of the endoscope, the channel plug, the injection tube, and the auxiliary water tube by wiping with clean lint-free cloths.5.5 manually cleaning the endoscope and accessories fill a clean, large basin with the detergent solution at the temperature and concentration recommended by the detergent manufacturer.- the scope is not soaked and goes directly into the rinse sink.5.5 manually cleaning the endoscope and accessories fill a clean, large basin with the detergent solution at the temperature and concentration recommended by the detergent manufacturer." olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III COLONOVIDEOSCOPE
• Type of Device: FLEXIBLE VIDEO COLONOSCOPE, REUSABLE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 15026297
• MDR Text Key: 301347637
• Report Number: 8010047-2022-11981
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170305191
• UDI-Public: 04953170305191
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCF-H190L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1